| Ilena Rose 2004-08-31, 7:15 pm |
| http://www.theolympian.com/home/new...ge/124486.shtml
Women talk of silicone breast implant operations gone awry
Others attend hearing to ask FDA to lift ban
Dr. Edward Melmed of Dallas shows the remains of a silicon gel breast
implant Tuesday during a breast implant hearing before a federal
advisory panel in Gaithersburg, Md. Melmed removed the implant from
one of his patients.
The Associated Press
THE ASSOCIATED PRESS
WASHINGTON -- The women told regulators of breast implants that caused
rock-like scars, of silicone leaching into their organs and oozing
through their skin, of unending pain.
Dozens of women and critics who blamed silicone gel breast implants
for damaging health effects urged the Food and Drug Administration on
Tuesday not to lift its 11-year ban on the devices.
But after they sat down, a line of other women pleaded for access to
the implants, calling them the most natural-feeling option to rebuild
cancer-ravaged breasts or enlarge healthy ones.
The FDA opened the two-day hearing to seek advice on whether Inamed
Corp. should be allowed to again sell silicone gel-filled breast
implants here, like it does in Europe. The two key issues being
debated are:
- Inamed's own research found 46 percent of breast cancer patients
getting silicone implants needed additional breast surgery within
three years -- as did one in five otherwise healthy women who had
breast enlargements.
- Whether Inamed has tracked women's health for a long enough period
after implantation. Its key study covered just three years. FDA's own
research suggests implants often break after seven years, and many
women report side effects once they've had the implants for a decade.
Inamed argues that many studies worldwide over the last decade have
exonerated silicone implants of causing serious disease, and that
short-term complications like painful scarring and extra surgery are
comparable to today's main option -- implants filled with salt water.
But women who say their silicone implants harmed them tell a different
story.
"My bones still scream with pain," breast cancer survivor Pam Dowd, of
Boise, Idaho, said at the hearing. She described having silicone
scraped off her chest wall when leaking implants were removed in 1995.
Carolyn Wolf of Centerville, Va., described "a long thin greasy glob"
of silicone oozing from her eye and X-rays showing it lodged elsewhere
in her body.
"We beg you, please protect the younger generation," she said.
Other women just as passionately defended the devices, noting that
today's saline implants have problems, too, and that men received
silicone testicular implants without concern.
Elizabeth Webber of Maryland told of her saline implants turning rock
hard and causing disabling pain, until she had them replaced with
silicone ones.
"I felt like myself, a whole natural and complete woman," Webber said.
"My breasts felt like mine."
"I'm offended that a woman's option to choose a silicone gel implant
was taken away," added Lisa Bancarz of California, who received gel
implants for enlargements in 1987.
But it was the critics' wrenching stories that appeared to move FDA
advisers. They grilled Inamed about why it couldn't provide long-term
studies proving how long implants really last.
Joanne Kuhne, a company executive, said Inamed planned to follow the
women for another seven years but wanted to resume sales while it did.
Ninety-three percent of women in the company's study remained
satisfied with the implant two years later, she told the panel.
Today's implants may break less often than those used 20 or 30 years
ago because doctors have made a key change, said Dr. Scott Spear, a
Georgetown university plastic surgeon and Inamed consultant. They used
to treat painful scar tissue by squeezing women's breasts to break it
up, which also could break the implant. "It's pretty clearly known ...
this is not a good idea," Spear said.
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For more on the dangers of breast implants, please visit:
www.BreastImplantAwareness.org
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